Manufacturing Engineer (Pharma/Biotech)

NUSANTARA PRIME CONSULTING PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading consulting firm in Singapore is seeking a candidate for a 9-month contract role focused on leading Change Records and supporting manufacturing operations in compliance with GMP regulations. The ideal candidate will have a Bachelor's degree in a relevant life science field, experience in a GMP environment, and strong organizational and communication skills. Join a dynamic team to enhance production processes and ensure safety protocols.

Qualifications

• Experience in Batch Record Creation within a GMP environment.
• Strong ability to work independently or as part of a team.
• Proven experience in leading project teams and facilitating root cause analysis.

Responsibilities

• Lead and execute multiple Change Records for Batch Records and SOPs.
• Support Change Records Assessment and GMP documentation Review.
• Collaborate with multidisciplinary teams to achieve project objectives.

Skills

Attention to detail

Organizational skills

Teamwork

Communication skills

Education

Bachelor's degree in a relevant life science field

Job description

Responsibilities

• Lead and execute multiple Change Records (Planned events) for the assigned area for creation of new Batch Records and Standard Operation Procedures for Production,
• Support Change Records Assessment and GMP documentation Review.
• Responsible for providing support to the assigned manufacturing operations by developing, coordinating and facilitating small to medium projects to ensure planned, predictable production operations in compliance with GMP regulations.
• Lead and execute Continuous Process Improvements, CAPAs and Change Records in assigned area.
• Provide routine and ad hoc support for planning, coordinating, execution, and performance improvement of key manufacturing processes such as product change over.
• Lead project teams to trouble shoot medium to complex problems and support continuous process improvement. Facilitate root cause analysis (RCA) with input from SMEs, develop and implement change to improve performance.
• Collaborate with multidisciplinary teams to achieve project objectives.
• Assist in experimental design and troubleshooting as needed.

About You

• Bachelor\'s degree in a relevant life science field (e.g., biology, biotechnology, biochemistry).
• Candidates with Batch Record Creation experience in a GMP environment in biologics or pharmaceutical industry are preferred.
• Strong attention to detail, organizational skills, and the ability to work independently or in a team.
• Excellent communication skills, both written and verbal, in English.
• Adherence to safety protocols and regulatory compliance.

Duration: 9-months contract role